Brief Title
Predicting Disease Progression and/or Recurrence in Cancer
Official Title
Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
Brief Summary
This is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy.
Detailed Description
This research study is evaluating how patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) in patient populations with colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy Massachusetts General Hospital Cancer Center - Patient reported outcomes will be collected through a series of self-administered questionnaires and blood draws will be used to obtain bio and tumor marker information. - Information will also be collected from the participants electronic medical record. - Tissue may be obtained for next-generation sequencing. - The study will conclude after participants are no longer receiving anti-cancer therapies. - It is expected that about 600 people will take part in this research study
Study Type
Observational
Primary Outcome
Treatment Response at 1st Scan
Secondary Outcome
Treatment Response at 1st Scan - Continuous Outcome
Condition
Patient Reported Outcome Measures
Intervention
Observational Cohort
Study Arms / Comparison Groups
Main Cohort
Description: Patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) Prior to starting anti-cancer therapy and at subsequent designated visits (every one month) Collections include: Blood sample Questionnaires quality of life, mood, and symptoms Tissue may be obtained for next-generation sequencing.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
600
Start Date
April 30, 2019
Completion Date
April 2024
Primary Completion Date
April 2023
Eligibility Criteria
- Inclusion Criteria: - Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer. - Diagnosed with metastatic disease - Age > 18 years. - Patients must be starting new line of anti-cancer therapy. - Patient must be English-speaking. - Exclusion Criteria - Unwilling or unable to participate in the study - Non-metastatic disease - Not starting new anti-cancer treatment - Cognitive issues interfering with ability to participate. - Active, unstable, untreated serious mental illness interfering with ability to participate. - Patient does not speak English.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Aparna R Parikh, MD, MS, (617) 724-4000, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04776837
Organization ID
18-380
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Study Sponsor
Aparna R Parikh, MD, MS, Principal Investigator, Massachusetts General Hospital
Verification Date
April 2022